Status:
COMPLETED
Study Comparing Foster Efficacy Maintenance and Reliever Versus Foster Maintenance + Salbutamol Reliever in Asthmatics
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Double-blind, multinational, multicentre, randomized, 2-arm parallel-group study
Detailed Description
To compare efficacy of Foster as maintenance therapy plus additional inhalations as reliever with Foster as maintenance plus salbutamol as reliever in asthmatics
Eligibility Criteria
Inclusion
- Written signed and dated informed consent obtained.
- Male or female patients aged ≥ 18 years.
- A positive reversibility test
- Patients who experienced at least one severe exacerbation in the 12 months before entry (but not in the last month)
- Using inhaled corticosteroids (ICS) in monotherapy or using ICS in a fixed or free combination with long acting beta2 agonists (LABA) at a constant dose for two months before screening visit
- Not fully controlled asthmatics (which means partly controlled or/and uncontrolled patients according to GINA guidelines 2007) in the last month before screening visit
- Forced expiratory volume in the first second (FEV1) ≥ 60% of predicted for the patient normal value.
- Non smokers or ex-smokers
Exclusion
- Pregnant or nursing (lactating) women. Women of child-bearing potential UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \>40 mIU/mL or are using one or more of acceptable methods of contraception
- Body Mass Index (BMI) \> 34 kg/m2.
- Patient with lower respiratory tract infections affecting the patient's asthma within 30 days of the screening visit.
- Use of systemic steroids in the last month.
- Patients with other lung diseases such as COPD, cystic fibrosis, interstitial lung diseases or any other clinically or functionally significant lung disorder.
- Patients who have an uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease.
- Clinically relevant laboratory abnormalities
- Patients who have an abnormal QTcF interval value
- Intolerance or contra-indication to treatment with beta2-agonists and/or ICS or allergy to any component of the study treatments.
- Patients treated with slow-release corticosteroids in the 3 months prior to screening visit.
- Patients being treated with anti-IgE antibodies.
- Patients treated with LABA or ICS/LABA fixed combination in the 24h before screening visit
- Severe asthma exacerbation in the last month before screening visit
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
2079 Patients enrolled
Trial Details
Trial ID
NCT00861926
Start Date
March 1 2009
End Date
April 1 2011
Last Update
March 30 2017
Active Locations (1)
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1
Pr Papi
Ferrara, Italy